Pharmaceuticals

Medicines, when used appropriately, are one of the most cost-effective health care interventions. In European countries, between 10% and 30% of health care expenditure goes on medicines, but at the same time in many countries scarce resources are wasted on drugs of little or questionable usefulness and on unnecessary drug use. Pharmaceutical policies in all countries are shaped not only by public health interests but also by economic considerations, the agendas of professional bodies, consumer’ s behaviour and the pharmaceutical industry. In all European countries, the state has the responsibility for regulating the entry of drug products onto the market, but compliance with and enforcement of the corresponding legislation is often unsatisfactory; in some countries,

drugs are imported and sold without the necessary professional control and guidance, and substandard drug products are currently a problem in several countries of the Region.

In NIS in particular, access to pharmaceuticals is seriously hampered by the economic hardships which the population are facing and the non-availability of drugs on the market, together with under-financed and unsustainable health insurance and reimbursement schemes.

In order to provide quality health care at an affordable cost, it is imperative that no funds are wasted on drugs of doubtful effectiveness, unnecessary prescribing or unnecessarily expensive medicines. European countries are already applying a mix of regulatory, administrative, financial, educational and information strategies. Measures include positive and negative lists of drugs for reimbursement; restrictions on prescribing and levels of dispensing; prescription auditing;

promotion of generics; and financial controls such as patient co-payments, fixed or indicative budgets for prescribers, price regulation and reference pricing.

PROPOSED STRATEGIES

The state has an important responsibility for setting standards and regulating the efficacy, safety and quality of medicinal products, as well as for guaranteeing that the whole population has access to needed medicines.

Pharmaceutical policies should focus on enhancing access to essential drugs and making best use of public and private expenditure, in order to provide quality health care through good drug treatment at an affordable cost. This entails:

• selecting the drugs to be used on the criteria of efficacy, safety and quality, and using cost–

effectiveness criteria for reimbursed drugs. WHO’ s essential drugs concept and the WHO revised drug strategy provide good starting points for doing this;

• securing sustainable sources of financing;

• organizing efficient and professionally responsible drug supply and delivery systems (whether public and/or private) which ensure that pharmaceuticals are accessible to those who need them;

• implementing strategies that support and reinforce the rational use of drugs.

New drug products should only enter the market if they meet the criteria of efficacy, safety and quality. When selecting a drug for inclusion in the reimbursement system, much greater emphasis needs to be placed on whether it truly has a measurably beneficial impact on the health outcome, whether it is superior to other treatments, and whether (from the health care perspective) it really needs to be paid for through public collective funds. The true impact of drug treatment on health outcome can only be assessed after several years, and this evaluation needs to be a continuous process. Information technology in post-market surveillance and pharmaco-epidemiology can provide the tools for better assessment and subsequent decision-making on these issues.

142 HEALTH21: the health for all policy framework for the WHO European Region

Policies should also be implemented to develop new drugs for unmet therapeutic needs.

Significant improvements in drug selection and use can be achieved by giving health professionals access to objective and impartial information on drugs and by bringing together clinicians, clinical pharmacologists and (clinical) pharmacists in pharmacotherapeutic committees in hospitals and ambulatory care settings. This requires active cooperation by all partners in health, including medical and pharmaceutical associations, the pharmaceutical industry, and consumers’ and patients’ groups. These groups play a vital role in enhancing the appropriate use of medicines and ensuring public and professional confidence in policy objectives and strategies.

Drug use can result in better health outcome only when patients are truly involved in and well informed about their condition and the goals of drug treatment. Health professionals have an increasing role to play in informing patients about the appropriate use of medicines. New information technology has great potential in this regard and needs to be further exploited.

PARTNERSHIP TO SAFEGUARD CONSUMERS’RIGHTS IN POLAND

In October 1994, the Polish Consumer Federation (PCF) launched an initiative with Health Action International to promote the rational use of drugs in Poland. In contrast with the shortages of drugs prior to 1989, it was found that there were now too many drugs, many of which were obsolete, ineffective, expensive and potentially harmful. The project’s main goals were consumer education and increasing consumers’ awareness of their rights. Initially, difficulties were experienced in securing the support of health professionals. Some physicians felt that decisions regarding drugs should be left exclusively to them. Pharmacists tended to be more supportive of the initiative.

A pamphlet Consumers and drugs was produced which contained information on the rational use of drugs and problem drugs on the market. The brochures were distributed to those responsible for developing and implementing national drug policies. The second step was to produce further information, entitled Med sense– which aimed to engender a more critical attitude among consumers towards drug promotion. The education strategy was heavily supported by television campaigns, print media and radio exposure. The project ended in 1995, with a seminar on rational drug use which brought together consumers and professionals to discuss the drug situation. The most visible success of the project was the high media exposure. Another effect was the strengthening of PCF’s role so that consumers are now taken more seriously by both the pharmaceutical industry and the health sector. The Ministry of Health gave an undertaking to withdraw the most dangerous drugs from the market. Other indicators of success include:

• increased use of the WHO essential drugs list;

• instruction of medical students in good prescribing practice;

• the Institute of Psychiatry and Neurology produced a leaflet for doctors on psychotropic treatment guidelines, in order to prevent drug dependency;

• growing interest in patients’ rights;

• increased media attention to rational drug use.

Source: London, Consumers’ International (unpublished data).